A Study of the Safety of Rabeprazole Administered to Adults With Gastroesophageal Reflux Disease (GERD)

NCT00216489 | Completed Phase 4

• 1 other identifier: CR003502
• Study Type: interventional
• Target: 191
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to confirm the safety and effectiveness of rabeprazole in the treatment of patients with erosive or ulcerative gastroesophageal reflux disease (GERD) in routine primary health care.

Conditions

Gastroesophageal Reflux; Heartburn

Keywords

gastroesophageal reflux; heartburn; rabeprazole; GERD; anti-ulcer agents; proton pump inhibitor

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events throughout treatment (8 weeks) and follow up (12 months)

Secondary Outcomes (1)

• Severity of symptoms at baseline and specified intervals during treatment and follow up, rated from "no problem" to "very severe problem"; physical examination and laboratory tests at end of treatment and after 4 months

Interventions

rabeprazole sodium DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with symptoms of erosive or ulcerative gastroesophageal reflux disease (GERD) during at least a period of 3 months prior to study initiation and symptoms of GERD for at least 3 days per week within the 2 weeks prior to study initiation. The symptoms of erosive or ulcerative gastroesophageal reflux disease includes the following: heartburn, aching behind the breastbone, a need for antacids, and difficulty in swallowing. Patients with evidence by endoscopy of erosive or ulcerative gastroesophageal reflux disease with no Barret-type tissue transformation.

You may not qualify if:

• No narrowing or inflammation of the esophagus
• no known gastro-duodenal ulcer
• no infections (other than H. Pylori), inflammations or hemorrhage of the stomach, small or large intestine
• no prior surgery of the stomach or intestine
• no known history of primary kinetic disorders of the esophagus, other than GERD
• no history of enlarged veins of the esophagus or stomach
• no pregnant or nursing females, or those lacking adequate contraception.

Sponsors & Collaborators

• Janssen Cilag Pharmaceutica S.A.C.I., Greece: lead

MeSH Terms

Conditions

Gastroesophageal Reflux; Heartburn

Interventions

Rabeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Janssen-Cilag Pharmaceutica S.A.C.I. Clinical Trial

  Janssen-Cilag Pharmaceutica S.A.C.I.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 22, 2005
• Study Start: March 1, 2003
• Study Completion: November 1, 2005
• Last Updated: April 26, 2010

Record last verified: 2010-04